Diaphragm IssuesSENNINCT04962568
Ultrasonographic Evaluation of the Diaphragm During NHF Versus NIV Use in Respiratory Failure
A study testing DTEE, DTEI and DEx in people with Diaphragm Issues and Respiratory Failure With Hypoxia, run by Jens Bräunlich at 1 site in Germany.
Trial summary
This study will describe influence of NHF or NIV to different ultrasonographic parameters of the diaphragm. Therefor subjects will be randomized to the sequence NHF and than NIV or NIV and than NHF. In all subjects same parameters will be evaluated. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Diaphragm Issues, Respiratory Failure With Hypoxia, Respiratory Failure With Hypercapnia
- What is being tested?
- DTEE, DTEI and DEx
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteGermany
- Study dates
- 7 Jul 2021to 5 Sep 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- acute or chronic respiratory failure, hyperemic or hypercapnic
- age > 18 yrs
- written consent
Who cannot join
- critical disease (intubation, heart failure, lung edema,..)
- no compliance
- metabolic acidosis
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
University of Leipzig
Leipzig
Jens Bräunlich, MD, 494921981551, highflow@web.de
About this study
This study will describe influence of NHF or NIV to different ultrasonographic parameters of the diaphragm. Therefor subjects will be randomized to the sequence NHF and than NIV or NIV and than NHF. In all subjects same parameters will be evaluated.
- Conditions
- Diaphragm Issues, Respiratory Failure With Hypoxia, Respiratory Failure With Hypercapnia, Non-invasive Mechanical Ventilation
- Being tested
- DTEE, DTEI, DEx
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DTEEDiagnostic test
endexpiratory diaphragm thickness in mm
DTEIDiagnostic test
endinspiratory diaphragm thickness in mm
DExDiagnostic test
diaphragm excursion during rest and diaphragmatic excursion during maximal inspiration in mm
| Study group | Role | What they receive |
|---|---|---|
| NHF-NIV | Experimental | Subjects will start with NHF. If all measurements are done, subjects will change to NIV. Same measurements will done. Receives: Diagnostic Test: DTEE; Diagnostic Test: DTEI; Diagnostic Test: DEx |
| NIV-NHF | Experimental | Subjects will start with NHF. If all measurements are done, subjects will change to NIV. Same measurements will done. Receives: Diagnostic Test: DTEE; Diagnostic Test: DTEI; Diagnostic Test: DEx |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in DTEE
Evaluation from baseline and between devices
Measured: 10 minutes
Secondary outcomes (2)
Changes in DTEI
Evaluation from baseline and between devices
Measured: 10 minutes
Changes in Dex
Evaluation from baseline and between devices
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2021
- Study start7 Jul 2021
- Primary completion7 Aug 2021
- Study completion5 Sep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diaphragm IssuesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jens Bräunlich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jens Bräunlich, Klinikum Emden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04962568
- Sponsor's protocol ID
- 2
- Acronym
- SENNI
- Status last verified
- Mar 2022
- First submitted
- 5 Jul 2021
- Last updated
- 31 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasonographic Evaluation of the Diaphragm During NHF Versus NIV Use in Respiratory Failure
- ClinicalTrials.gov ID
- NCT04962568
- Acronym / sponsor ID
- SENNI / 2
- Conditions
- Diaphragm Issues, Respiratory Failure With Hypoxia, Respiratory Failure With Hypercapnia, Non-invasive Mechanical Ventilation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Jens BräunlichUniversity, hospital or other
- Study start
- 7 Jul 2021 (actual)
- Primary completion
- 7 Aug 2021 (actual)
- Study completion
- 5 Sep 2022 (estimated)
- First posted
- 15 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will describe influence of NHF or NIV to different ultrasonographic parameters of the diaphragm. Therefor subjects will be randomized to the sequence NHF and than NIV or NIV and than NHF. In all subjects same parameters will be evaluated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NHF-NIV | Experimental | Diagnostic Test: DTEE, Diagnostic Test: DTEI, Diagnostic Test: DExSubjects will start with NHF. If all measurements are done, subjects will change to NIV. Same measurements will done. |
| NIV-NHF | Experimental | Diagnostic Test: DTEE, Diagnostic Test: DTEI, Diagnostic Test: DExSubjects will start with NHF. If all measurements are done, subjects will change to NIV. Same measurements will done. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- acute or chronic respiratory failure, hyperemic or hypercapnic
- age > 18 yrs
- written consent
Key exclusion criteria (3 listed)
- critical disease (intubation, heart failure, lung edema,..)
- no compliance
- metabolic acidosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DTEEendexpiratory diaphragm thickness in mm | Diagnostic test | NHF-NIV, NIV-NHF |
| DTEIendinspiratory diaphragm thickness in mm | Diagnostic test | NHF-NIV, NIV-NHF |
| DExdiaphragm excursion during rest and diaphragmatic excursion during maximal inspiration in mm | Diagnostic test | NHF-NIV, NIV-NHF |
Primary outcome
Changes in DTEE
Time frame: 10 minutes
Evaluation from baseline and between devices
2 secondary outcomes
Changes in DTEI
Time frame: 10 minutes
Changes in Dex
Time frame: 10 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2022.
- Individual participant dataSharing planned: Undecided
Related trials for Diaphragm Issues
RecruitingObservational study
Diaphragm Atrophy and Dysfunction in Mechanical Ventilation
Diaphragm Issues, Mechanical Ventilation Complication
Not yet recruitingObservational study
Reliability of Diaphragm Ultrasound: Intra- and Interrater Analysis
Diaphragm Issues
Not yet recruiting
Comparison of the Interscalene Block Alone Versus Combined With Superior Truncus Block During Shoulder Surgery in Diaphragmatic Function
Diaphragm Issues
Recruiting
STIMIT Activator 1 IDE Study
Diaphragm Issues
Not yet recruitingObservational study
The Effect of BIPAP on Diaphragmatic Function
BIPAP Biphasic Intermittent Positive Airway Pressure, Diaphragm Issues
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DTEE, DTEI and DEx in people with Diaphragm Issues and Respiratory Failure With Hypoxia, run by Jens Bräunlich at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in DTEE (time frame: 10 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2022.